MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PXB35-08-37-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Prior to a procedure to stent bilateral common iliac arteries, pictures taken showed stenosis on the left common femoral and the bilateral iliac arteries.A 6x40x135 evercross balloon was used for bilateral iliac pre-dilation.Access for the procedure was achieved though the right common femoral artery.It was reported that a 8x57x80 visipro was placed in the right common iliac while a 8x37x80 vis-pro was placed in the left common iliac.Both stents were reported to have been deployed at the same time.It was reported that the left side was done first followed by the right side.Post deployment images showed no evidence of leaks or bleeding.Post-procedure it was reported that the patient developed complications and died.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7354863
• Report Number: 2183870-2018-00164
• Device Sequence Number: 1470618
• Product Code: FGE
• UDI-Device Identifier: 00821684036501
• UDI-Public: 00821684036501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2021
• Device Catalogue Number: PXB35-08-37-080
• Device Lot Number: A583674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR